Clinical trial · Interventional
Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers
A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) work in treating patients with biliary cancers (which includes the gallbladder and bile ducts inside and outside the liver) that have spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIIA Gallbladder Cancer AJCC v7 | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Gallbladder Cancer AJCC v7 | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Intrahepatic Cholangiocarcinoma AJCC v7 | Intrahepatic Cholangiocarcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Gallbladder Cancer AJCC v7 | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7 | Intrahepatic Cholangiocarcinoma | CURATED_BROADER | 0.78 |
| Stage IVB Gallbladder Cancer AJCC v7 | Malignant Gallbladder Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (nab-paclitaxel, cisplatin, gemcitabine)
- description
- Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Cisplatin
- Drug: Gemcitabine Hydrochloride
- Other: Laboratory Biomarker Analysis
- Drug: Nab-paclitaxel
Primary outcomes (1)
- measure
- Median Progression Free Survival (PFS)
- timeFrame
- up to 3 years
- description
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer or may undergo a repeat biopsy for histologic confirmation if pre-existing biopsy is not sufficient for diagnosis * Metastatic or unresectable disease documented on diagnostic imaging studies * May not have received prior chemotherapy; if patient has received prior adjuvant therapy, must be \> 6 months from treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 * Platelets \>= 100,000/ul * Hemoglobin \> 9.0 g/dL * Total bilirubin =\< 1.5 mg/dL (in patients with known Gilbert's syndrome direct bilirubin =\< 1.5 x upper limit of normal \[ULN\] will be used as organ function criteria, instead of total bilirubin) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = \< 5 x ULN * Creatinine =\< 1.5 gm/dL * Negative serum or urine pregnancy test in women with childbearing potential (WOCBP) defined as not post-menopausal for 12 months or no previous surgical sterilization, within one week prior to initiation of treatment; WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy * A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy; if the partner is pregnant or breastfeeding, the subject must use a condom * Patients must sign an informed consent and authorization indicating that they are aware of the investigational nature of this study and the known risks involved Exclusion Criteria: * Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0; in CTCAE version 4.0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)" * Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection * Pregnancy (positive pregnancy test) or lactation * Known central nervous system (CNS) disease, except for treated brain metastasis; treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]) during the screening period; anticonvulsants (stable dose) are allowed; treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear accelerator \[LINAC\], or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 will be excluded
References
Publications (1)
- DERIVEDShroff RT, Javle MM, Xiao L, Kaseb AO, Varadhachary GR, Wolff RA, Raghav KPS, Iwasaki M, Masci P, Ramanathan RK, Ahn DH, Bekaii-Saab TS, Borad MJ. Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):824-830. doi: 10.1001/jamaoncol.2019.0270. PMID 30998813